Catherine M. Sullivan

Effect of Food Additives on Hyperphosphatemia Among Patients With End-stage Renal Disease: A Randomized Controlled Trial

CONTEXT High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well. To prevent hyperphosphatemia, patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus. However, phosphorus-containing additives are increasingly being added to processed and fast foods. The effect of such additives on serum phosphorus levels is unclear. OBJECTIVE To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio. Two hundred seventy-nine patients with elevated baseline serum phosphorus levels (>5.5 mg/dL) were recruited between May and October 2007. Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were randomly assigned to an intervention or control group. INTERVENTION Intervention participants (n=145) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants. Control participants (n=134) continued to receive usual care. MAIN OUTCOME MEASURE Change in serum phosphorus level after 3 months. RESULTS At baseline, there was no significant difference in serum phosphorus levels between the 2 groups. After 3 months, the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants (95% confidence interval, -1.0 to -0.1 mg/dL). Intervention participants also had statistically significant increases in reading ingredient lists (P<.001) and nutrition facts labels (P = .04) but no significant increase in food knowledge scores (P = .13). CONCLUSION Educating end-stage renal disease patients to avoid phosphorus-containing food additives resulted in modest improvements in hyperphosphatemia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00583570.

Impact of Navigators on Completion of Steps in the Kidney Transplant Process: A Randomized, Controlled Trial

BACKGROUND AND OBJECTIVES Many patients with ESRD, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These eight sequential steps are as follows: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. This study sought to determine the effect of navigators on completion of steps. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Cluster randomized, controlled trial at 23 Ohio hemodialysis facilities. One hundred sixty-seven patients were recruited between January 2009 and August 2009 and were followed for up to 24 months or until study end in February 2011. Trained kidney transplant recipients met monthly with intervention participants (n=92), determined their step in the transplant process, and provided tailored information and assistance in completing the step. Control participants (n=75) continued to receive usual care. The primary outcome was the number of transplant process steps completed. RESULTS Starting step did not significantly differ between the two groups. By the end of the trial, intervention participants completed more than twice as many steps as control participants (3.5 versus 1.6 steps; difference, 1.9 steps; 95% confidence interval, 1.3-2.5 steps). The effect of the intervention on step completion was similar across race and sex subgroups. CONCLUSIONS Use of trained transplant recipients as navigators resulted in increased completion of transplant process steps.

The Prevalence of Phosphorus-Containing Food Additives in Top-Selling Foods in Grocery Stores

OBJECTIVE The objective of this study was to determine the prevalence of phosphorus-containing food additives in best-selling processed grocery products and to compare the phosphorus content of a subset of top-selling foods with and without phosphorus additives. DESIGN The labels of 2394 best-selling branded grocery products in northeast Ohio were reviewed for phosphorus additives. The top 5 best-selling products containing phosphorus additives from each food category were matched with similar products without phosphorus additives and analyzed for phosphorus content. Four days of sample meals consisting of foods with and without phosphorus additives were created, and daily phosphorus and pricing differentials were computed. MAIN OUTCOME MEASURES Presence of phosphorus-containing food additives, phosphorus content. RESULTS Forty-four percent of the best-selling grocery items contained phosphorus additives. The additives were particularly common in prepared frozen foods (72%), dry food mixes (70%), packaged meat (65%), bread and baked goods (57%), soup (54%), and yogurt (51%) categories. Phosphorus additive-containing foods averaged 67 mg phosphorus/100 g more than matched nonadditive-containing foods (P = .03). Sample meals comprised mostly of phosphorus additive-containing foods had 736 mg more phosphorus per day compared with meals consisting of only additive-free foods. Phosphorus additive-free meals cost an average of

Fast food, phosphorus-containing additives, and the renal diet.

2.00 more per day. CONCLUSION Phosphorus additives are common in best-selling processed groceries and contribute significantly to their phosphorus content. Moreover, phosphorus additive foods are less costly than phosphorus additive-free foods. As a result, persons with chronic kidney disease may purchase these popular low-cost groceries and unknowingly increase their intake of highly bioavailable phosphorus.

Public Health Approach to Addressing Hyperphosphatemia Among Dialysis Patients

OBJECTIVE Fast food is commonly consumed by hemodialysis patients, but many menu items are not compatible with renal diets because of their sodium, potassium, or phosphorus content. Moreover, the phosphorus content of fast foods is difficult for patients to estimate, because phosphorus-containing additives are commonly added to many fast foods. We sought to determine how many fast-food entrees and side dishes are compatible with renal diets. METHODS We examined nutrition-facts labels and ingredient lists provided by 15 fast-food chains. Each entree and side dish was first assessed according to traditional criteria (limited sodium, potassium, and naturally occurring phosphorus content), and then according to the presence of a phosphorus -containing additive. RESULTS Of 804 total entrees across all restaurants, 415 (52%) were acceptable according to traditional criteria, but only 128 (16%) were also free of phosphorus-containing additives. Of 163 total side dishes, 37 (23%) were acceptable according to traditional criteria, and 27 (17%) were also free of phosphorus-containing additives. There were no acceptable entrees at 3 chains, and no acceptable side dishes at 5 chains. CONCLUSION Only a small proportion of fast-food entrees and side dishes are compatible with renal diets. The widespread use of phosphorus-containing additives is a major impediment to the availability of acceptable fast-food choices for hemodialysis patients. We recommend limiting the use of phosphorus-containing additives, and including phosphorus content in nutrition-facts labels.

Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial.

Elevated serum phosphorus levels are a major source of morbidity and mortality for the 350,000 Americans receiving chronic dialysis treatment. Despite the widespread application of medical and behavioral interventions, the prevalence of hyperphosphatemia remains exceedingly high. At first glance, a public health perspective may seem inappropriate for addressing a disorder of mineral metabolism among patients receiving a life-sustaining treatment. However, we analyzed this topic from a public health perspective and identified many opportunities to improve the management of hyperphosphatemia, including (1) media and cultural messages about food, (2) the availability of appropriate foods and medications, (3) physical structures such as the location of products in grocery stores, and (4) social structures such as food-labeling laws.

The adequacy of phosphorus binder prescriptions among American hemodialysis patients.

ABSTRACTBACKGROUNDLow organ donation rates remain a major barrier to organ transplantation.OBJECTIVEWe aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider.DESIGNThis was a randomized controlled trial between February 2013 and May 2014.SETTINGThe waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio.PATIENTSThe study included 915 patients over 15.5 years of age who had not previously consented to organ donation.INTERVENTIONSJust prior to their clinical encounter, intervention patients (n = 456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n = 459) visited their provider per usual routine.MAIN MEASURESThe primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter.KEY RESULTSIntervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10–2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1–20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61–1.25).LIMITATIONHow the observed increases in organ donation consent might translate into a greater organ supply is unclear.CONCLUSIONWatching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected.TRIAL REGISTRATIONclinicaltrials.gov Identifier: NCT01697137

Phosphorus-Containing Food Additives and the Accuracy of Nutrient Databases: Implications for Renal Patients

Because hemodialysis treatment has a limited ability to remove phosphorus, dialysis patients must restrict dietary phosphorus intake and use phosphorus binding medication. Among patients with restricted dietary phosphorus intake (1000 mg/d), phosphorus binders must bind about 250 mg of excess phosphorus per day and among patients with more typical phosphorus intake (1500 mg/d), binders must bind about 750 mg/d. To determine the phosphorus binding capacity of binder prescriptions among American hemodialysis patients, we undertook a cross-sectional study of a random sample of in-center chronic hemodialysis patients. We obtained data for one randomly selected patient from 244 facilities nationwide. About one-third of the patients had hyperphosphatemia (serum phosphorus level > 5.5 mg/dL). Among the 224 patients prescribed binders, the mean phosphorus binding capacity was 256 mg/d [standard deviation (SD) 143]. A total of 59% of prescriptions had insufficient binding capacity for restricted dietary phosphorus intake, and 100% had insufficient binding capacity for typical dietary phosphorus intake. Patients using two binders had a higher binding capacity than patients using one binder (451 vs. 236 mg/d, p < 0.001). A majority of binder prescriptions have insufficient binding capacity to maintain phosphorus balance. Use of two binders results in higher binder capacity. Further work is needed to understand the impact of binder prescriptions on mineral balance and metabolism and to determine the value of substantially increasing binder prescriptions.